JP2008036446A - Blade having functional equilibrium asymmetrical part used with ultrasonic surgical instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an ultrasonic surgical instrument combined with a blade shaped to optimize the performance of the instrument. <P>SOLUTION: The shape of the blade 88 is characterized by a cut part rounded to form a curved shape. The cut part forms a curved surface having a plurality of asymmetrical parts to thereby generate a plurality of non-equilibrium parts in the blade 88. The non-equilibrium by curving of the instrument is corrected by a non-functional asymmetrical part adjacent to the functional asymmetrical part. The non-equilibrium due to the asymmetrical section of the blade is corrected by suitable selection of volume and position of material removed from a functional asymmetrical part. The shape of the blade according to one embodiment is characterized by two cut parts rounded to form a curved or tapered shape in some case. Two cut parts form a curved surface including a recessed and projecting surfaces. The length of the rounded cut part partially acts on acoustic equilibrium of transverse motion caused by the curved shape. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

Detailed Description of the Invention

(Field of the Invention)
The present invention relates generally to ultrasonic surgical instruments and, more particularly, to a multifunctional curved blade having a functional asymmetric portion for use with an ultrasonic surgical instrument to minimize unwanted motion.

BACKGROUND OF THE INVENTION
This patent application includes the following co-pending patent applications: US patent application Ser. No. 08 / 948,625 filed Oct. 10, 1997, No. 08 filed Oct. 10, 1997. No./949,133, 09 / 106,686 filed on June 29, 1998, 09 / 337,077 filed on June 21, 1999, 09 / 412,557, 09 / 412,996, and 09 / 413,225, which are incorporated herein by reference.

  Ultrasound instruments, including hollow core and solid core instruments, are used for the safe and effective treatment of many medical conditions. Ultrasound instruments, particularly solid core ultrasound instruments, are used to cut and / or coagulate organic tissue using energy in the form of mechanical vibrations that are transmitted to the surgical end-effector at ultrasonic frequencies This is advantageous. Ultrasonic vibration can be used to cut, incise, or cauterize tissue when transmitted to organic tissue at an appropriate energy level and using an appropriate end-effector. Ultrasonic instruments that utilize solid core techniques are particularly advantageous because of the amount of ultrasonic energy that can be transmitted from the ultrasonic transducer through the waveguide to the surgical end-effector. These instruments are particularly suitable for use in minimally invasive procedures, including endoscopic or laparoscopic procedures, where the end-effector reaches the surgical site through the trocar.

  Ultrasonic vibrations are induced in the surgical end-effector by electrically exciting a transducer that can be comprised of, for example, one or more piezoelectric transducer elements or magnetostrictive elements in the instrument hand piece. Vibrations generated by the transducer portion are transmitted to the surgical end-effector via an ultrasonic waveguide that extends from the transducer portion to the surgical end-effector. These waveguides and end-effectors are designed to resonate at the same frequency as the transducer. Therefore, when the end-effector is attached to the transducer, the overall system frequency remains the same as the transducer itself.

The amplitude d of the ultrasonic vibration in the longitudinal direction at the end portion functions as a simple sine wave at the resonance frequency given as follows.
d = Asin (ωt) (Formula 1)
In this formula:
ω = angular frequency equal to 2π times the periodic frequency f,
A = zero-to-peak amplitude.
The longitudinal operating range is defined as peak-to-peak (ptp) amplitude, which is exactly twice the amplitude of the sine wave, ie 2A.

  Solid core ultrasonic surgical instruments can be divided into two types of devices: single-element end-effector devices and multi-element end-effectors. Single element end-effector devices include instruments such as surgical scalpels and ball coagulators, see, eg, US Pat. No. 5,263,957. While instruments such as those disclosed in US Pat. No. 5,263,957 are known to be quite satisfactory, there are some limitations in their use as well as in other ultrasonic surgical instruments. is there. For example, single element end-effector devices have limited ability to apply pressure from the blade to the tissue when the tissue is soft and gently supported. Sufficient pressure is required to effectively transmit ultrasonic energy to the tissue. If the tissue cannot be reliably captured in this manner, it cannot be completely adhered to the tissue surface during the supply of ultrasonic energy, resulting in insufficient hemostasis and tissue bonding.

  The use of multi-element end-effectors, such as clamp coagulators, includes a mechanism for pressing tissue against an ultrasonic blade, which eliminates the disadvantages described above. Clamping mechanisms disclosed as useful in ultrasonic surgical devices are described in US Pat. Nos. 3,636,943 and 3,862,630 issued to Balamuth. In general, however, the Balamuth apparatus disclosed in these patents does not solidify and cut at a sufficient rate, and the approach to the blade is blocked by the clamp and cannot be used for cutting / coagulation without the clamp. Lack of flexibility.

  For example, ultrasonically clamped coagulation devices such as those disclosed in US Pat. Nos. 5,322,055 and 5,893,835 are gently supported or not supported at all. An improved ultrasonic surgical instrument for cutting / coagulating tissue is provided, where an ultrasonic blade is used in conjunction with a clamp to apply a constant compressive or biasing force to the tissue. Thus, relatively fast tissue coagulation and cutting can be achieved, and blade motion attenuation can be relatively reduced.

  An improvement in the technique of curved ultrasound instruments as described in US patent application Ser. No. 09 / 106,686, previously incorporated herein by reference, is another aspect of curved clamped coagulation. It shows the need for improvement in the device. For example, US Pat. No. 5,873,873 describes an ultrasonically clamped coagulation instrument that includes an end-effector that includes a clamp arm having a tissue pad. In the configuration disclosed in US Pat. No. 5,873,873, the clamp arm and tissue pad are straight.

  The shape of the ultrasonic surgical blade or end-effector used in the clamp coagulator defines at least four important aspects of the instrument. These are (1) the visibility of the end-effector and its relative position within the surgical field, (2) the ability of the end-effector to approach or enter the targeted tissue, and (3) the ultrasonic energy is cut off. And (4) the manner in which the tissue can be manipulated by an ultrasonically inert end-effector. Therefore, it would be advantageous to provide an improved ultrasonic clamp coagulator that optimizes these four aspects of the instrument.

  However, as each feature is added to the blade of an ultrasonic surgical instrument, its altered shape and asymmetrical portion cause the blade to lose balance, resulting in a variety of blades that differ from the longitudinal direction along the length of the instrument. It tends to vibrate in the direction. US patent application Ser. No. 09 / 106,686, previously incorporated herein by reference, addresses the balancing of the blade portion on the proximal side of each functional asymmetric portion using a balancing asymmetric portion. ing. Although this US patent application Ser. No. 09 / 106,686 has proven to be significantly effective in balancing each blade and waveguide section proximal to the asymmetric section for balancing, In applications, some of the balancing effects may be undesirable in the functional part of the asymmetric blade.

  Therefore, it would be desirable to have an ultrasonic surgical instrument blade balanced in the functional area of the blade to optimize instrument performance. The blades described herein have been developed to address such needs.

[Summary of the Invention]
The present invention discloses an ultrasonic surgical instrument that combines end-effector shapes to best perform the numerous functions of a shear-type configuration. The blade shape is characterized by a cut-offset portion that is rounded a certain distance to form a curved shape. The cutting portion forms a curved surface portion having a number of asymmetric portions that result in a number of unbalanced portions in the blade. The non-equilibrium due to the curved surface in this device is corrected by the non-functional asymmetric part on the proximal side of the functional asymmetric part. Also, non-equilibrium due to the asymmetric cross-sectional portion of the blade is corrected by appropriate selection of the volume and location of material removed from the functional asymmetric portion. The shape of the blade in an example embodiment of the present invention is characterized by two cut-offset portions that are rounded a certain distance to form a curved and potentially tapered shape. These two cut portions form a curved surface portion including a concave surface portion and a convex surface portion. The length of these rounded cuts acts in part in the acoustical balancing of the lateral movement induced by the curved shape described above.

Detailed Description of the Invention
Hereinafter, the present invention will be described in combination with an ultrasonic instrument as described herein. This description is merely exemplary and is not intended to limit the scope and application of the present invention. For example, the present invention relates to US Pat. Nos. 5,938,633, 5,935,144, 5,944,737, 5,322,055, and 5,630,420. And in combination with a number of ultrasonic instruments including those described in US Pat. No. 5,449,370.

  FIG. 1 illustrates an ultrasound system 10 that includes an ultrasound signal generator 15 with an ultrasound transducer 82, a hand piece housing 20, and a clamped coagulator 120 according to the present invention. The clamp-type coagulation device 120 can be used in open or laparoscopic surgery. The ultrasonic transducer 82 is known as a “Langevin stack” and is generally a transduction portion 90, a first resonator or end-bell 92, and a second resonator or fore-bell 94, And has auxiliary parts. The ultrasonic transducer 82 preferably has a length (nλ / 2) that is an integral multiple of ½ of the system wavelength, as will be described in detail later. The acoustic assembly 80 includes the ultrasonic transducer 82, the mounting member 36, the velocity transformer 64, and the surface portion 95 described above.

  The distal end portion of the end bell 92 is connected to the proximal end portion of the transduction portion 90, and the proximal end portion of the forebell 94 is connected to the distal end portion of the transduction portion 90. Fore-bell 94 and end-bell 92 are the thickness of transduction portion 90, the density and modulus of the materials used to make end-bell 92 and fore-bell 94, and the resonance of ultrasonic transducer 82. It has a certain length determined by a number of variables including the frequency. The fore-bell 94 can be tapered inward from its base end to its tip so that the velocity transformer 64 can amplify the amplitude of the ultrasonic vibration, or may not have an amplifying function. .

  The piezoelectric transducer 100 can be made of any suitable material including, for example, zirconate-lead titanate, meta-lead niobate, lead titanate, or other piezoelectric transducing crystal material. Each of the positive electrode 96, the negative electrode 98, and the piezoelectric conversion element 100 has a bore hole penetrating the center thereof. Further, the positive electrode 96 and the negative electrode 98 are electrically connected to the electric wire 102 and the electric wire 104, respectively. Each electric wire 102 and electric wire 104 are encased in a cable 25 and can be electrically connected to the ultrasonic signal generator 15 in the ultrasonic system 10.

  The ultrasonic transducer 82 of the acoustic assembly 80 converts the electrical signal from the ultrasonic signal generator 15 into mechanical energy, which is primarily longitudinal at the ultrasonic frequency of the ultrasonic transducer 82 and the end-effector 180. Oscillates in the direction. A suitable generator is available as model number GEN01 from Ethicon Endo-Surgery, Cincinnati, Ohio. When the acoustic assembly 80 is excited, a standing wave of vibration operation is generated in the acoustic assembly 80. Further, the amplitude of the vibration motion at any point along the acoustic assembly 80 is determined by the location along the acoustic assembly 80 at which the vibration motion is measured. The minimum position or zero-crossing position in the standing wave of this oscillating motion is commonly referred to as the node (ie, the motion is usually minimum), and the absolute maximum position in this standing wave Or the peak position is commonly referred to as the anti-node. Further, the distance between the antinode and the nearest node is ¼ wavelength (λ / 4).

  Each electric wire 102 and electric wire 104 transmit electrical signals from the ultrasonic signal generator 15 to the positive electrode 96 and the negative electrode 98, respectively. The piezoelectric transducer 100 is excited by an electrical signal supplied from the ultrasonic signal generator 15 in response to the foot switch 118 to generate an acoustic standing wave in the acoustic assembly 80. That is, this electrical signal causes a large compressive force in this material by causing turbulence in the form of repeated small displacements in each piezoelectric transducer element 100. That is, a small wave in the repeated state causes each piezoelectric transducer element 100 to expand and contract in a continuous manner along the axis of its voltage gradient, thereby generating a longitudinal wave of ultrasonic energy. This ultrasonic energy is transmitted to the end-effector 180 via the acoustic assembly 80.

  In order for the acoustic assembly 80 to provide energy to the end-effector 180, all components in the acoustic assembly 80 are acoustically applied to each ultrasonically active portion of the clamp coagulator 120. Must be concatenated. For example, the front end portion of the ultrasonic transducer 82 can be acoustically coupled to the proximal end portion of the ultrasonic waveguide 179 at the surface portion 95 by a threaded connecting means such as the stud 50.

Each component in the acoustic assembly 80 is preferably acoustically tuned so that the length of the arbitrary assembly is an integral multiple of a half wavelength (nλ / 2). The wavelength λ in this case is the predetermined wavelength or the driving frequency f _d of vibration along the longitudinal direction for operation of the acoustic assembly 80, and n is a positive integer. It should be noted that the acoustic assembly 80 described above can include any suitable arrangement of acoustic elements.

  2A and 2B, a clamped coagulator 120 in the surgical system 10 according to the present invention is shown. Preferably, the clamp-type solidification device 120 is attached to and detached from the acoustic assembly 80 as a single unit. Preferably, the proximal end of the clamp coagulator 120 is acoustically coupled to the distal surface portion 95 of the acoustic assembly 80 as shown in FIG. It will be appreciated that the clamp coagulator 120 can be coupled to the acoustic assembly 80 by any suitable means.

  Preferably, the clamp coagulation device 120 includes an instrument housing 130 and an elongated member 150. The elongate member 150 can be selectively rotated relative to the instrument housing 130 as described in detail below. The instrument housing 130 includes a pivotable handle portion 136 and fixed handles 132A and 132B that are coupled to the left shroud 134 and the right shroud 138, respectively.

  The right shroud 138 is adapted to snap fit on the left shroud 134. Preferably, the right shroud 138 is connected to the left shroud 134 by a plurality of inwardly facing prongs 70 formed in the right shroud 138. The plurality of prongs 70 are arranged to engage within corresponding holes or holes 140 formed in the left shroud 134. When the left shroud 134 is attached to the right shroud 138, a cavity is formed between them that fits various components, such as a designation mechanism 255 as described in detail below.

  The left shroud 134 and the right shroud 138 in the clamp-type solidification device 120 are preferably made of polycarbonate. It is contemplated that these components can be made from any suitable material without departing from the spirit and scope of the present invention.

  The designation mechanism 255 is disposed in a cavity in the instrument housing 130 described above. Preferably, the designation mechanism 255 is connected or attached to the inner tube 170 to convert the movement of the handle portion 136 into a linear motion of the inner tube 170 to open and close the clamp arm assembly 300. That is, when the pivotable handle portion 136 moves in the direction of the fixed handle portion 130, the designation mechanism 255 causes the inner tube 170 to slide rearward to pivot the clamp arm assembly 300 to a closed state. When the pivoting handle portion 136 moves in the opposite direction, the designation mechanism 255 slides to move the inner tube 170 in the opposite direction, i.e., forward, and the clamp arm assembly is moved. Rotate 300 to its open state.

  The designation mechanism 255 also includes a ratchet mechanism that allows the elongated member 150 to rotate about its longitudinal axis relative to the instrument housing 130. This rotation of the elongate member 150 allows the clamp arm 300 to rotate to a selected desired angular position. The designation mechanism 255 preferably includes a tubular collar 260 and a yoke 280.

  The tubular collar 260 of the designation mechanism 255 described above is preferably snapped onto the proximal end of the inner tube 170 and keyed into the opposite opening 168. This tubular collar 260 is preferably made of polyetherimide. The tubular collar 260 can be made of any appropriate material.

  The tubular collar 260 is shown in more detail in FIGS. Preferably, the tubular collar 260 has an enlarged portion 262 and a bore 266 extending therethrough. The enlarged portion 262 preferably includes a ring 272 formed around the periphery of the tubular collar 260 and forming a groove 268. The groove 268 has a plurality of detents or teeth 269 that hold the elongated member 150 in different rotational positions as the elongated member 150 rotates about its longitudinal axis. Act on. Preferably, the groove 268 has twelve ratchet teeth to allow the elongated portion to rotate by twelve equiangular increments of about 30 degrees. The tubular collar 260 can have an arbitrary number of tooth-like members. It will also be appreciated that these toothed members can be placed in any suitable portion of the tubular collar 260 without departing from the scope and spirit of the present invention.

  Returning now to FIGS. 2A-4, the pivotable handle portion 136 has a thumb loop 142, a first hole 124, and a second hole 126. A pivot pin 153 is disposed in the first hole 124 of the handle portion 136 to allow pivoting as indicated by arrow 121 in FIG. When the thumb loop 142 of the pivoting handle portion 136 moves away from the instrument housing 130 in the direction of arrow 121, the link 128 applies a constant forward force to the yoke 280, causing the yoke 280 to move forward. Moving. The link 128 is connected to the pivotable handle portion 136 by a pin 129, and the link 128 is connected to the base 284 by a pin 127.

  Returning now to FIG. 2A, the yoke 280 generally has a holding or support member 282 and a base 284. The support member 282 is preferably semi-circular and has a pair of opposing claws 286 that extend inward to engage the teeth 269 of the tubular collar 260. It is contemplated that these pawls 286 can be placed on any suitable portion of the yoke 280 for engagement with the teeth 269 of the tubular collar 260 without departing from the spirit and scope of the present invention. It will also be appreciated that the yoke 280 may have any number of ratchet arms.

  The yoke 280 is shown in more detail in FIGS. The pivoting handle portion 136 is preferably partially disposed in a slot 147 in the base 284 of the yoke 280. The base 284 has a base opening 287, an actuator movement stop 290, and a base pin-hole 288. The pivot pin 153 is disposed through the base opening 287. Each pawl 286 in the yoke 280 transmits an opening force to the inner tube 170 via the tubular collar 260, thereby opening the clamp and arm assembly 300.

  The yoke 280 in the clamp-type solidification device 120 is preferably made of polycarbonate. The yoke 280 can also be made from a variety of materials including other plastic materials such as ABS, nylon, or polyetherimide. Further, it is contemplated that this yoke 280 can be constructed from any suitable material without departing from the spirit and scope of the present invention.

  As shown in FIGS. 3 and 4, the yoke 280 transmits a constant closing force to the clamp arm assembly 300 as the pivoting handle portion 136 moves toward the instrument housing 130. The actuator movement stop 290 contacts the pivot pin 153 at the bottom of the stroke of the pivoting handle portion 136 to prevent further movement, i.e., excessive movement, of the pivoting handle portion 136. Each pawl 286 of the yoke 280 transmits force to the tubular collar 260 via a washer 151, a force limiting spring 155, and a collar cap 152. The collar cap 152 is firmly attached to the tubular collar 260 after the washer 151 and the force limiting spring 155 are assembled on the tubular collar 260 proximal to the enlarged portion 262. This collar cap 152 is shown in more detail in FIGS. Also, the force limiting spring 155 is shown in more detail in FIGS. 7 and 8, and the washer 151 is shown in more detail in FIGS. The thickness of the washer 151 can be adjusted during the design or manufacture of the clamped solidification device 120 to change the preload of the force limiting spring 155. The collar cap 152 is attached to the tubular collar 260 by ultrasonic welding, but can be press fit, snap fit, or attached by adhesive.

  5-10, the tubular collar 260, washer 151, force limiting spring 155, and collar cap 152 include force limiting features in the clamp arm assembly 300. As the pivoting handle portion 136 moves toward the instrument housing 130, the clamp arm assembly 300 rotates toward the ultrasonic blade 88. It is desirable to limit the maximum force of the clamp arm assembly 300 to 0.5 pounds to 3.0 pounds (0.227 kg to 1.362 kg) for both ultrasonic cutting and hemostasis.

  FIGS. 5 and 6 show the collar cap 152 including the spring surface 158. FIGS. 7 and 8 show a force limiting spring 155 including a cap surface portion 156, a washer surface portion 157, and a plurality of spring elements 159. This force limiting spring 155 is described in the art as a wave spring due to the shape of its spring element 159. The use of such a wave spring in the force limiting spring 155 exhibits a high spring rate in small physical dimensions where the spring is well suited for ultrasonic surgical instrument applications, where: This is advantageous because its central region is open for the ultrasonic waveguide 179. The force limiting spring 155 is biased between the spring surface portion 158 of the collar cap 152 and the spring face 165 of the washer 151. The washer 151 has a claw surface portion 167 (FIGS. 9 and 10) that comes into contact with each claw 286 of the yoke 280 after assembly of the clamp-type solidification device 120 (see FIGS. 2 to 4).

  2A, 2B, and FIGS. 14-18, a rotary knob 190 is attached to the elongate member 150 to rotate the elongate member 150 and the tubular collar 260 rotates relative to the yoke 280. It is supposed to be. The rotary knob 190 can also be made from a variety of materials including another plastic material such as polyetherimide, nylon, or any other suitable material.

  Preferably, the rotary knob 190 has an enlarged portion or outer knob 192, an inner knob 194, and an axial bore 196 extending therethrough. The inner knob 194 has a key 191 for cooperatively attaching to the keyway 189 of the outer knob 192. Outer knob 192 has alternating longitudinal ridges 197 and grooves 198 that facilitate the orientation of rotating knob 190 and elongate member 150 by the surgeon. The axial bore 196 of the rotary knob 190 is configured to fit properly over the proximal end of the elongated member 150.

  Inner knob 194 extends into opening 139 at the distal end of instrument housing 130. The inner knob 194 has a channel 193 for rotatably mounting the inner knob 194 in the opening 139. In addition, the inner knob 194 of the rotatable knob 190 has a pair of opposed holes 199. Each of these opposing holes 199 is aligned as part of a passage 195 that passes through an elongated member 150 as described below.

  For example, a connecting member such as a pin 163 can be disposed in each of the opposing holes 199 in the passage 195. The pin 163 can be captured between ribs in the housing 130 or held in the passage 195 of the elongated member 150 by any suitable means including an adhesive such as silicone or cyanoacrylate. This pin 163 allows rotational torque to be applied to the elongate member 150 from the rotary knob 190 to rotate the elongate member 150.

  When the rotary knob 190 is rotated, the teeth 269 of the tubular collar 260 are engaged with the corresponding claws 286 of the yoke 280 and slightly ride up. When these pawls 286 ride on the teeth 269, the support member 282 of the yoke 280 is deflected outward, allowing each pawl 286 to slide over the teeth 269 of the tubular collar 260. To do.

  In an example embodiment, the tooth portion 269 of the tubular collar 260 is configured as an inclined portion or a raised portion, and each claw 286 of the yoke 280 is configured as a post portion. Further, the tooth portions 269 of the tubular collar 260 and the claws 286 of the yoke 280 are reversed, the tooth portions 269 of the tubular collar 260 are used as post portions, and the claws 286 of the yoke 280 are used as inclined portions or raised portions. You can also. In addition, it is thought that said tooth | gear part 269 can be integrally formed in the peripheral part of the elongate member 150, or can be directly connected. Further, the tooth portion 269 and each claw 286 can be provided with a cooperative protruding portion, raised portion, cam surface, ratchet-like tooth portion, sawtooth portion, raised portion without departing from the spirit and scope of the present invention. It will be appreciated that can be a flange, or other similar means that cooperate to allow the elongated member 150 to be designated at a selective angular position.

  As shown in FIG. 2B, the elongate member 150 in the clamped coagulator 120 extends from the instrument housing 130. As shown in FIGS. 2B-4, the elongate member 150 preferably includes an outer member or outer tube 160, an inner member or inner tube 170, and a transmission component or ultrasonic waveguide 179.

  The outer tube 160 of the elongate member 150 preferably has a hub 162, a tubular member 164, and a longitudinal opening or hole 166 extending therethrough. The outer tube 160 also preferably has a substantially circular cross section and can be made of stainless steel. It will be appreciated that the outer tube 160 can be constructed of any suitable material and can have any suitable cross-sectional shape.

  The hub 162 of the outer tube 160 preferably has a larger diameter than the tubular member 164. The hub 162 has a pair of tube holes 161 for receiving the pin 163 and allowing the hub 162 to be connected to the rotary knob 190. As a result, the outer tube 160 rotates when the rotary knob 190 rotates or rotates.

  The hub 162 of the outer tube 160 further has a wrench flat portion 169 on each surface portion on the opposite side of the hub 162. These wrench flats 169 are preferably formed near the tip of the hub 162. Further, these wrench flat portions 169 allow the ultrasonic wave guide 179 to be fixed to the stud 50 of the acoustic assembly 80 by supplying torque to the hub 162 with a torque wrench. For example, U.S. Pat. Nos. 5,059,210 and 5,057,119, which are incorporated herein by reference, provide torque torque for attaching and detaching transmission components to an attachment device in a hand piece assembly. A wrench is disclosed.

  An end-effector 180 for performing various operations such as tissue gripping, tissue cutting, and the like is disposed at the distal end portion of the tubular member 164 in the outer tube 160 described above. It is conceivable that the end-effector 180 can be formed in any appropriate configuration.

  The above end-effector 180 and its components are shown in more detail in FIGS. The end-effector 180 generally includes a non-vibrating clamp and arm assembly 300 for grasping tissue or pressing tissue against the blade 88, for example. The end-effector 180 is also shown in a clamp open state in FIGS. 23 and 26, and the clamp arm assembly 300 is preferably pivotably attached to the distal end of the outer tube 160.

  23-26, the clamp arm assembly 300 preferably includes a clamp arm 202, a jaw hole 204, a first post portion 206A, a second post portion 206B, and a tissue pad 208. . Clamp arm 202 is pivotally attached to pivot pin 207A and pivot pin 207B so that when thumb loop 142 moves in the direction indicated by arrow 121 in FIG. It rotates in the direction of 122. By advancing the pivotable handle portion 136 toward the instrument housing 130, the clamp arm 202 pivots about the pivot pin 207A and pivot pin 207B to the closed state. Also, by retracting the pivoting handle portion 136 away from the instrument housing 130, the clamp arm 202 pivots into an open state.

  The clamp arm 202 has a tissue pad 208 attached to the clamp arm 202 for sandwiching tissue between the ultrasonic blade 88 and the clamp arm assembly 300. The tissue pad 208 is preferably formed of a polymer or other flexible material and engages the ultrasonic blade 88 when the clamp arm 202 is in its closed state. Preferably, the tissue pad 208 is, for example, TEFLON® (Teflon®), a trade name of EI Du Pont de Nemours and Company, which corresponds to polymeric polytetrafluoroethylene (PTFE), It is made of a material that has a constant low coefficient of friction but is substantially rigid to demonstrate the ability to grasp tissue. The tissue pad 208 can be attached to the clamp arm 202 by an adhesive, preferably a mechanical fixation structure as described below.

  As shown in FIGS. 23, 26, and 28, the sawtooth portion 210 is formed on the clamping surface of the tissue pad 208 and extends perpendicular to the axis of the ultrasonic blade 88. Thus, the tissue can be grasped, manipulated, coagulated and cut without sliding the tissue between the clamp arm 202 and the ultrasonic blade 88.

  Tissue pad 208 is shown in more detail in FIGS. The tissue pad 208 has a T-shaped protruding portion 212, a left protruding surface portion 214, a right protruding surface portion 216, an upper surface portion 218, and a lower surface portion 219. The lower surface portion 219 has the saw tooth portion 210 already described. In addition, the tissue pad 208 has a beveled front end 209 for ease of insertion during assembly as described below.

  In FIG. 26, the distal end portion of the tubular member 174 in the inner tube 170 preferably has a finger portion or a flange portion 171 extending from the distal end portion. The flange portion 171 has openings 173A and 173B (not shown) for receiving the first post portion 206A and the second post portion 206B of the clamp arm 202, respectively. Thus, when the inner tube 170 of the elongated member 150 moves in the axial direction, the flange portion 171 engages with the first post portion 206A and the second post portion 206B of the clamp arm assembly 300 while moving forward. Alternatively, the clamp arm 202 is opened and closed by moving backward.

  24, 25 and 31-33, the clamp arm 202 of the end-effector 180 is shown in further detail. The clamp arm 202 has an arm upper portion 228 and an arm lower portion 230, and a straight portion 235 and a curved portion 236. The straight portion 235 has a straight T-shaped slot 226. The curved portion 236 includes a first upper hole 231, a second upper hole 232, a third upper hole 233, a fourth upper hole 234, a first lower notch 241 and a second lower notch. Portion 242, third lower notch 243, fourth notch 244, first shelf 221, second shelf 222, third shelf 223, fourth shelf 224, and 5 shelves 225.

  The hole 231 extends from the arm upper part 228 to the second shelf 222 through the clamp arm 202. The hole 232 extends from the upper arm 228 to the third shelf 223 through the clamp arm 202. The hole 233 extends from the upper arm 228 to the fourth shelf 224 via the clamp arm 202. Further, the hole 234 extends from the arm upper part 228 through the clamp arm 202 to the fifth shelf 225. The arrangement of each of these holes 231 through 234 and each of the shelves 221 through 225 allows the clamp arm 202 to include both the straight portion 235 and the curved portion 236 described above. Molding is possible by a method such as metal injection molding (MIM). The clamp arm 202 can be made of stainless steel or other suitable metal by utilizing the MIM method described above.

  In FIGS. 30 and 31, the T-shaped protrusion 212 on the tissue pad 208 can be inserted into the T-shaped slot 226 of the clamp arm 202. The clamp arm 202 is designed such that the tissue pad 208 can be manufactured as a linear part, for example, by injection molding, machining, or extrusion. The beveled front end 209 facilitates bending of the tissue pad 208 as it is inserted into its straight T-shaped slot 226 and advanced into the curved portion 236 at the clamp arm 202. To match the curvature of. Further, the arrangement of the holes 231 to 234 and the shelves 221 to 225 enables the clamp arm 202 to bend and hold the tissue pad 208.

  32 and 33 illustrate how the clamp arm 202 holds the tissue pad 208 while maintaining the flexed state of the tissue pad 208 with respect to the curved portion 236 of the clamp arm 202. FIG. It is. As shown in FIG. 32, the third shelf 223 contacts the right protruding surface portion 216 to form the contact edge portion 238, but the left protruding surface portion 214 is not supported at this position. On the other hand, in the position on the tip side shown in FIG. 33, the fourth shelf 224 contacts the left protruding surface portion 214 to form the contact edge portion 239, but the right protruding surface portion 216 Not supported in position.

  Returning now to FIG. 2, the inner tube 170 of the elongate member 150 is properly fitted within the opening 166 of the outer tube 160. The inner tube 170 is preferably an inner hub 172, a tubular member 174, an outer circumferential groove 176, a pair of opposed openings 178, a pair of opposed openings 168, and a longitudinal opening therethrough. Part or hole 175. The inner tube 170 preferably has a substantially circular cross section and can be made of stainless steel. It will be appreciated that the inner tube 170 can be constructed of any suitable material and can be any suitable shape.

  The inner hub 172 in the inner tube 170 preferably has a larger diameter than the tubular member 174. Also, the pair of opposed openings 178 in the inner hub 172 allows the inner hub 172 to receive the pin 163 so that the inner tube 170 and the ultrasonic wave guide 179 have the ultrasonic wave guide as already described. Torque for attaching the tube 179 to the stud 50 can be transmitted. The O-ring 220 is preferably disposed in the outer circumferential groove 176 of the inner hub 172.

  The ultrasonic waveguide 179 in the elongated member 150 extends into the hole 175 of the inner tube 170. The ultrasonic waveguide 179 is preferably substantially semi-flexible. It will be appreciated that the ultrasonic waveguide 179 may be substantially rigid or may be a flexible wire member. Thereby, ultrasonic vibration is transmitted in the longitudinal direction along the ultrasonic waveguide 179 to vibrate the ultrasonic blade 88.

  The ultrasonic waveguide 179 may have a length substantially equal to an integral multiple (nλ / 2) of ½ of the system wavelength, for example. The ultrasonic waveguide 179 can be preferably made of a solid core shaft made of a material that efficiently propagates ultrasonic energy, such as a titanium alloy (ie, Ti-6Al-4V) or an aluminum alloy. . It is conceivable that this ultrasonic waveguide 179 can be manufactured from any other suitable material. The ultrasonic waveguide 179 can also amplify mechanical vibrations transmitted to the ultrasonic blade 88 as is well known in the art.

  As shown in FIG. 2, the ultrasonic waveguide 179 has one or more stabilizing silicone rings or damping sheaths disposed at various locations around the periphery of the ultrasonic waveguide 179. 110 (one shown). The damping sheath 110 dampens undesired vibrations and separates the ultrasonic energy from the inner tube 170 to ensure that the ultrasonic energy is longitudinally extended to the tip of the ultrasonic blade 88 with maximum efficiency. introduce. The attenuation sheath 110 can be secured to the ultrasonic waveguide 179 by an interference fit, such as the attenuation sheath described in US patent application Ser. No. 08 / 808,652, incorporated herein by reference.

  Further, in FIG. 2, the ultrasonic waveguide 179 generally has a first portion 182, a second portion 184, and a third portion 186. The first portion 182 of the ultrasonic waveguide 179 extends from the proximal end portion of the ultrasonic waveguide 179 to the distal end side. The first portion 182 has a substantially continuous constant cross-sectional dimension.

  The first portion 182 preferably has at least one radial hole 188 extending therethrough. The waveguide hole 188 extends substantially perpendicular to the axis of the ultrasonic waveguide 179. The waveguide hole 188 is preferably located at the node, but could be located at any other suitable location along the ultrasonic waveguide 179. It will be appreciated that the waveguide hole 188 can have any suitable depth and can have any suitable shape.

  The waveguide holes 188 in the first portion 182 are aligned with the opposing openings 178 in the hub 172 and the outer tube holes 161 in the hub 162 to receive the pins 163. Pin 163 allows rotational torque to be applied from rotating knob 190 to ultrasonic waveguide 179 to rotate elongate member 150. The passage 195 in the elongate member 150 includes opposing openings 178, outer tube holes 161, waveguide holes 188, and opposing holes 199.

  The second portion 184 in the ultrasonic waveguide 179 extends from the first portion 182 to the distal end side. The second portion 184 has a substantially continuous constant cross-sectional dimension. The diameter of the second portion 184 is smaller than the diameter of the first portion 182. Thereby, the ultrasonic energy is transmitted from the first portion 182 to the second portion 184 in the ultrasonic waveguide 179, and the ultrasonic energy passing through the portion by the portion narrowed in the second portion 184. Is amplified.

  Further, the third portion 186 extends from the distal end portion of the second portion 184 to the distal end side. The third portion 186 has a substantially continuous constant cross-sectional dimension. The third portion 186 can also have a small diameter that varies along its length. This third portion preferably has a seal 187 formed around the outer periphery of the third portion 186. Thereby, the ultrasonic energy is transmitted from the second portion 184 in the ultrasonic waveguide 179 into the third portion 186, and passes through the portion by the portion narrowed in the third portion 186. The amplitude of the ultrasonic energy is amplified.

  The third portion 186 can have a plurality of grooves or notches (not shown) formed in the outer peripheral portion thereof. These grooves are each node of the ultrasonic waveguide 179 or any other suitable location along the ultrasonic waveguide 179 to act as an alignment indicator for mounting the damping sheath 110 during manufacture. It is possible to arrange in

  Further, in FIG. 2, the damping sheath 110 in the surgical instrument 150 surrounds at least a portion of the ultrasonic waveguide 179. The damping sheath 110 is disposed around the ultrasonic waveguide 179, and can suppress or limit vibration from the lateral side surface to the side surface of the ultrasonic waveguide 179 during operation. This damping sheath 110 preferably surrounds a portion of the second portion 184 of the ultrasonic waveguide 179. It is also conceivable that the damping sheath 110 can be disposed around any appropriate portion of the ultrasonic waveguide 179. The damping sheath 110 preferably extends at least one antinode in lateral vibration, and more preferably in a plurality of antinodes in lateral vibration. Further, the damping sheath 110 preferably has a substantially circular cross section. It will be appreciated that the damping sheath 110 can have any suitable shape that fits over the ultrasonic waveguide 179 and can have any suitable length.

  The damping sheath 110 is preferably in light contact with the ultrasonic waveguide 179 to absorb unwanted ultrasonic energy from the ultrasonic waveguide 179. This damping sheath 110 reduces the non-axial vibration amplitude of the ultrasonic waveguide 179, including unwanted lateral vibrations associated with longitudinal frequencies of 55,500 Hz and above and below. To do.

  The damping sheath 110 is preferably made of a polymer material having a constant low friction coefficient in order to minimize energy loss due to the axial movement of the ultrasonic waveguide 179, that is, longitudinal vibration. Yes. The polymeric material is preferably floura-ethylene propene (FEP), which is resistant to decay during sterilization by gamma radiation. It will be appreciated that the damping sheath 110 described above can be manufactured from any suitable material, such as PTFE, for example.

  The damping sheath 110 preferably has an opening therethrough and a longitudinal slit 111. The slit 111 of the damping sheath 110 allows the damping sheath 110 to be combined on the ultrasonic waveguide 179 from either end. It will be appreciated that the damping sheath 110 may have any suitable configuration that allows the damping sheath 110 to fit over the ultrasonic waveguide 179. For example, the damping sheath 110 may be formed as a coil or spiral, or may have various patterns of longitudinal and / or circumferential slits or slots. Further, the damping sheath 110 can be manufactured without the slit 111, and the ultrasonic waveguide 179 can be manufactured with two or more parts for fitting into the damping sheath 110. Conceivable.

  It will be appreciated that the ultrasonic waveguide 179 described above may have any suitable cross-sectional dimension. For example, the ultrasonic waveguide 179 may have a substantially uniform cross section, and the ultrasonic waveguide 179 may be tapered in various portions, or over its entire length. It may be tapered.

  The ultrasonic waveguide 179 can also amplify mechanical vibrations transmitted to the ultrasonic blade 88 via the ultrasonic waveguide 179 as is well known in the art. Further, the ultrasonic waveguide 179 has features for controlling the longitudinal vibration gain along the ultrasonic waveguide 179 and to tune the ultrasonic waveguide 179 to the resonant frequency of the system. Can have the following features.

  The proximal end of the third portion 186 in the ultrasonic waveguide 179 can be coupled to the distal end of the second portion 184 by an internal threaded connection means, preferably near the antinode. In addition, it is thought that this 3rd part 186 can be attached to the said 2nd part 184 by arbitrary appropriate means, such as welding joining. This third portion 186 includes an ultrasonic blade 88. Although the ultrasonic blade 88 can be separable from the ultrasonic waveguide 179, the ultrasonic blade 88 and the ultrasonic waveguide 179 are preferably formed as a single unit.

  The ultrasonic blade 88 may have a length that is substantially equal to an integral multiple of 1/2 the system wavelength (nλ / 2). Also, the tip of the ultrasonic blade 88 can be placed near the antinode to provide maximum longitudinal displacement at the tip. Thus, when the transducer assembly described above is excited, the tip of the ultrasonic blade 88 operates at a predetermined vibration frequency, for example, about 10 to 500 microns peak-to-peak operation, preferably about 30 microns to Configured to move within the 150 micron range.

  The ultrasonic blade 88 is preferably made of a solid core shaft made of a material that propagates ultrasonic energy, such as a titanium alloy (ie, Ti-6Al-4V) or an aluminum alloy. It will be appreciated that the ultrasonic blade 88 can be made of any other suitable material. It is further contemplated that the ultrasonic blade 88 may have a surface treatment to improve energy delivery and desired tissue action. For example, the ultrasonic blade 88 can be microfinished, coated, plated, etched to enhance coagulation and tissue cutting ability and / or reduce tissue and blood adhesion to the end-effector. Can be grit blasted, roughened or scored. In addition, the ultrasonic blade 88 can be sharpened or shaped to enhance its properties. For example, the ultrasonic blade 88 may have a blade shape, a hook shape, or a ball shape.

  As shown in FIGS. 34, 35 and 36, the shape of the ultrasonic blade 88 according to the present invention provides ultrasonic power to the clamped tissue more uniformly than existing devices. The end-effector 180 provides improved visibility of the blade end portion so that the surgeon can confirm that the blade 88 extends across the structure being cut or coagulated. This is particularly important when checking the edges of large blood vessels. This shape also provides improved tissue access by further mimicking the curved portions of biological structures. The blade 88 is designed to perform a number of tissue actions: clamped coagulation, clamped cutting, grasping, dorsal cutting, incision, spot coagulation, end part invasion and end part scoring. It has a large number of edge portions and surface portions.

  The most distal portion of the blade 88 has a surface portion 54 that is perpendicular to the tangent 63, that is, the line tangent to the curved portion at the tip portion. Also, two fillet-like feature portions 61A and feature portions 61B are used to mix the surface portions 51, 52 and 54, thereby forming a blunt tip portion that can be used for spot coagulation. . Also, the upper portion of the blade 88 is rounded or blunted to form a wide edge portion or surface portion 56 for clamping tissue between the blade 88 and the clamp arm assembly 300. This surface portion 56 is used for the cutting and coagulation process in the clamped state and also for manipulating the tissue when the blade is inactive.

  Further, the lower surface portion has a spherical cut portion 53 that forms a narrow edge portion, that is, a sharp edge portion 55, along the bottom portion of the blade 88. The material is cut by, for example, a narrower second radius R2 in which the above-mentioned cutting portion is mixed with the bottom portion 58 of the blade 88 after sweeping the mill at the spherical end in an arc shape having the radius R1. Can be achieved by finishing. The radius R1 is preferably in the range of 0.5 inches to 2 inches (1.27 cm to 5.08 cm), more preferably in the range of 0.9 inches to 1.1 inches (2.29 cm to 2.79 cm). Of these, the most preferred is about 1.068 inches (2.713 cm). Also, the radius R2 is preferably 0.125 inches to 0.5 inches (0.318 cm to 1.27 cm), and most preferably about 0.25 inches (0.64 cm). The mixed portion of the second radius R2 and the corresponding bottom surface portion 58 of the blade 88 has a stress concentrated on the end of the spherical cut portion as compared with the case where the mixed portion is stopped in a cut state without the mixed portion. Decrease. The sharp edge 55 facilitates incision and unclamped cuts (back cuts) in less vascular tissue.

  The spherical cut portion 53 at the bottom surface 58 of the blade 88 forms a sharp edge 55 and removes a minimum amount of material from the blade 88. The spherical cut portion 53 at the bottom of the blade 88 forms a sharp edge 55 having a constant angle α as will be described below. This angle α can be similar to existing shear devices such as LCS-K5 manufactured by Ethicon Endo-Surgery, Cincinnati, Ohio. However, the blade 88 of the present invention can be cut faster than existing devices due to the orientation of the angle α described above with respect to its general supply force. In the case of an existing shear device, each edge portion is symmetrical, and the supply force is evenly spread. On the other hand, each edge portion in the present invention is asymmetric, and the asymmetry of the edge portion indicates a high speed in separating or cutting tissue. That is, this asymmetry is important in providing a sharper edge effectively when activated by ultrasound without removing large volumes of material while maintaining a dull shape. Also, this asymmetrical angle as well as the curved portion of the blade acts to tension the tissue itself during the back cut by a slight hook-like or wedge-like action.

  The sharp edge portion 55 of the ultrasonic blade 88 is defined by a line of intersection between the surface portion 53 and the second surface portion 57 left after the bottom surface portion 58 receives the spherical cut portion 53. The clamp arm assembly 300 pivots relative to the ultrasonic blade 88 and is pivotable to the distal end of the outer tube 160 to clamp tissue between the clamp arm assembly 300 and the ultrasonic blade 88. It is attached. As a result, the reciprocating movement of the inner tube 170 causes the clamp / arm assembly 300 to turn in an arc shape to define the vertical plane 181. The tangent line 60 of the spherical cut portion 53 at the sharp edge 55 defines a constant angle α with respect to the tangent line 62 of the second surface portion 57 as shown in FIG. The bisector 59 of this angle α is preferably not in the vertical plane 181 and is offset by an angle β. Preferably, the tangent line 60 of the spherical cut portion 53 is in the range of about 5 to 50 degrees with respect to the vertical plane 181 and most preferably the tangent line of the spherical cut portion 53 is vertical. It exists at about 38.8 degrees from the plane 181. Preferably, the angle α is in the range of about 90 to 150 degrees, and most preferably the angle α is about 121.6 degrees.

  In FIG. 35A, another embodiment of the present invention is shown with an asymmetric narrow edge. The tangent 60A of the spherical cut portion 53A at the sharp edge portion 55A defines a certain angle αA with respect to the tangent 62A of the second surface portion 57A as shown in FIG. 35A. The bisector 59A of this angle αA is preferably not in the vertical plane 181A and is offset by a certain angle βA.

  The curved shape in the design of the ultrasonic blade 88 described above further results in a more evenly distributed energy supply to the tissue when the tissue is clamped against the blade. Such uniform energy supply is desirable because it achieves a constant tissue action (thermal and cross-sectional action) along the length of the end-effector 180. The most advanced 15 millimeter portion of the blade 88 is the working portion and is used to achieve a certain tissue action. As will be described in detail later, the displacement vector corresponding to each location along the curved shear blade 88 is shown in FIGS. 34 and 35 by various improvements of the present invention over existing instruments. -Respectively present in the y plane. Therefore, the movement of the blade 88 is in a certain plane (xy plane) perpendicular to the direction of the clamping force from the clamp arm assembly 300.

  In general, a linear symmetric ultrasonic blade has a distal portion deflection that lies along the longitudinal axis indicated by the x-axis in FIGS. Also, lateral movement is usually undesirable because this movement causes unwanted heat generation within the inner tube 170. Thus, a functionally asymmetric part including a curved end-effector as described in US patent application Ser. No. 09 / 106,686, previously incorporated herein by reference, is an ultrasonic blade. In addition, this functionally asymmetric part forms a non-equilibrium part in the ultrasonic waveguide. If this non-equilibrium part is not appropriate, undesired heat, noise, and impaired tissue effects result. The above-mentioned US patent application Ser. No. 09 / 106,686 teaches a method for providing an ultrasonic blade that is balanced proximally relative to the asymmetric portion for balancing, but the tip of the end-effector. The portion has a deviation in at least two axial directions. So, if this end-effector has a single plane functional asymmetric part like a curved end-effector and the blade is otherwise symmetric, then the deflection is its leading edge. It exists in a certain plane in the part.

  In many cases, it is desirable to minimize the deflection of any ultrasonic blade 88 in the z-axis direction. This deviation of the ultrasonic blade 88 in the z-axis direction makes the system inefficient and creates the potential for unwanted heat generation, power loss, and noise generation. The displacement of the ultrasonic blade 88 in the z-axis direction in the end-effector 180 gives an impact by the ultrasonic blade 88 to the tissue existing between the ultrasonic blade 88 and the clamp arm assembly 300. . Therefore, it is desirable to limit the deviation of the ultrasonic blade 88 with respect to the xy plane shown in FIGS. This allows the ultrasonic blade 88 to rub the tissue present between the ultrasonic blade 88 and the clamp arm assembly 300 without impact, thereby optimizing the tissue heat generation. Optimal coagulation treatment can be performed. Minimizing the deviation in the z-axis direction in both the portion proximal to the end-effector 180 and the portion in the ultrasonic blade 88 can be achieved by appropriate selection of the spherical cut portion 53. .

  However, an ultrasonic end-effector 180 with an ultrasonic blade 88 having multiple functional asymmetric parts, including an ultrasonic blade 88 as shown in FIGS. 34-36, must be properly balanced. There is essentially a tendency to include end portion deviations in all three axes x, y and z. For example, an ultrasonic blade 88 as shown in FIG. 34 is curved in the y-axis direction at its tip. This curved portion is balanced more proximally than the end-effector 180, but the curved portion has respective deflections in both the x-axis and y-axis directions when the ultrasonic blade 88 is activated. Acts as follows. Further, by adding the above-mentioned spherical cutting portion 53, another amount of asymmetrical portion is added to the ultrasonic blade 88. If it is not appropriate, the end portion is deviated in all three axes. Further, a non-equilibrium action in the z-axis direction also occurs in the ultrasonic waveguide 179, and the efficiency is lowered.

  Therefore, by supplying a functional asymmetric portion optimized to minimize the deviation in the z-axis direction in the ultrasonic waveguide 179, the z-axis on the proximal side of the functional asymmetric portion is provided. Deviations in the end portion of the direction can be minimized and efficiency can be maximized with improved tissue action. As shown in FIG. 34, the spherical cut portion 53 can extend from the most distal portion to an arbitrary position in the ultrasonic blade 88 toward the proximal end side. For example, FIG. 34 shows a first position 66, a second position 67, and a third position 68 for a spherical cut 53 that extends into the ultrasonic blade 88.

  Table 1 below shows a possible cut of the spherical cut 53 in the case of an ultrasonic blade 88 as shown in FIG. 34 as the first position 66, the second position 67 and the third position 68. Each length is listed. Each horizontal row in Table 1 represents the length of the cut into the ultrasonic blade 88, and each vertical row in Table 1 represents the equilibrium state for each cut length and the deviation along each axis. Yes. From Table 1, when the spherical cut portion 53 is supplied to a length corresponding to the first position 68, the deviation in the z-axis direction on the base end side from the functional asymmetric portion is minimized. I understand. Note that it is preferable to equilibrate the ultrasonic blade 88 so that the displacement in the z-axis direction on the base end side with respect to the functional asymmetric portion is 15% or less. Most preferably, the ultrasonic blade 88 is balanced so that the displacement in the z-axis direction on the side is 5% or less. Preferably, the clamped coagulator 120 is designed to be balanced when activated in air (loaded by air only), and the equilibrium is not a separate load. Confirmed under conditions.

機能的な非対称部分を含むブレードによるＴｉ６Ａ１４Ｖにより製造したＲ１の半径を有する０．９４６インチ（２．４０３ｃｍ）の長さのブレードにおいて一定範囲の平衡作用を示すための３種類の可能な長さ In Table 1, the normalized deflection rate (% z) in the clamping device at the end-effector 88 is in the direction perpendicular to the clamping arm when the clamping arm is in its fully closed state. Calculated by measuring the magnitude of the deviation, dividing this magnitude by the largest end portion vibration excursion (also called the primary end portion vibration excursion) and then multiplying that dividend by 100. . The vibration displacement of the primary end portion is the size of the main axis of the ellipse or ellipsoid formed by one point at the most distal portion of the ultrasonic blade 88 when the ultrasonic blade 88 is activated. The above deviation measurement is further described in IEC International Standard 61847 entitled Measurement and Declaration of the Basic Output Characteristics, which is included herein as a reference. It has been explained in detail. Further, the standardized deviation rate (% x,% y,% z) in the ultrasonic blade 88 or the ultrasonic waveguide 179 measures the magnitude of the secondary vibration deviation, and determines the magnitude. Calculated by dividing the dividend by 100 after dividing by the magnitude of the vibration displacement of the primary end portion. The above-mentioned secondary vibration excursion is a size of an ellipse or a short axis of an ellipsoid formed by one point at the most distal portion of the ultrasonic blade 88 when the ultrasonic blade 88 is activated or another arbitrary axis. is there.

Three possible lengths to show a range of equilibration effects in a 0.946 inch (2.403 cm) long blade with a radius of R1 manufactured by Ti6A14V with a blade containing a functional asymmetric part

  Next, a procedure for attaching and detaching the clamp-type solidification device 120 to / from the acoustic assembly 80 will be described below with reference to FIGS. When the doctor is ready to use the clamp coagulator 120, the doctor simply attaches the clamp coagulator 120 to the acoustic assembly 80. In order to attach the clamp type solidification device 120 to the acoustic assembly 80, the distal end portion of the stud 50 is connected to the transmission component, that is, the proximal end portion of the ultrasonic waveguide 179 with a screw. Thereafter, the clamp-type solidification device 120 is manually rotated in a conventional screw tightening direction to interlock a screw joint portion between the stud 50 and the ultrasonic waveguide 179.

  After the ultrasonic waveguide 179 is screwed to the stud 50, for example, a tool such as a torque wrench is placed on the elongated member 150 of the clamping coagulator 120 to place the ultrasonic waveguide 179 in the stud 50. Tighten against. The tool can be configured to engage the wrench flat portion 169 of the hub 162 in the outer tube 160 to secure the ultrasonic waveguide 179 on the stud 50. As a result, the rotation of the hub 162 causes the elongate member 150 to rotate until the ultrasonic waveguide 179 is secured to the stud 50 with a desired and predetermined torque. It should be noted that the torque wrench described above may be used as a part of the clamp-type coagulator 120 or as a torque wrench described in US Pat. No. 5,776,155, which is incorporated herein by reference. It is conceivable that it can be manufactured separately as part of the piece housing 20.

  After attaching the clamp coagulator 120 to the acoustic assembly 80, the surgeon can rotate the rotary knob 190 to adjust the elongated member 150 to a desired angular position. As the rotary knob 190 is rotated, the teeth 269 of the tubular collar 260 slide over the pawls 286 of the yoke 280 into the adjacent notches or valleys. As a result, the surgeon can position the end-effector 180 in the desired orientation. The rotary knob 190 can incorporate designation means for designating a rotational relationship between the instrument housing 130 and the clamp arm 202. As shown in FIGS. 17 and 18, for example, by utilizing an enlarged ridge 200, one of the ridges 197 in the rotation knob 190 can be rotated by the clamp arm 202 relative to the instrument housing 130. Can be used to specify the position of the direction. It should be noted that other designation means, including the use of colors, symbols, surface patterns, etc., may be used in the rotary knob 190 to designate the position as in the use of the enlarged ridge 200.

  To separate the clamped coagulator 120 from the stud 50 of the acoustic assembly 80, the tool is slid over the elongate member 150 of the surgical instrument 120 in the opposite direction, ie, an ultrasonic waveguide. 179 can be rotated in a direction to release the screw engagement with the stud 50. When this tool is rotated, the hub 162 of the outer tube 160 allows torque to be applied to the ultrasonic waveguide 179 via the pin 163, so that a relatively high disengagement torque is applied to the ultrasonic waveguide. 179 is added to rotate in the direction of its screw disengagement. As a result, the ultrasonic waveguide 179 is loosened away from the stud 50. Thus, after the ultrasonic waveguide 179 is removed from the stud 50, the entire clamped coagulator can be ejected.

While preferred embodiments of the present invention have been illustrated and described herein, it will be apparent to those skilled in the art that these embodiments are provided for illustrative purposes only. That is, at this point, numerous variations, modifications, and substitutions will occur to those skilled in the art without departing from the invention. Accordingly, the invention is to be considered limited only by the spirit and scope of the appended claims.
The novel features of the invention are set forth with particularity in the appended claims. However, the present invention itself, together with further objects and advantages thereof, may be best understood by reference to the detailed description taken in conjunction with the following accompanying drawings, both for its construction and method of operation.

Embodiment
(1) In the ultrasonic clamp type coagulator
A housing having an actuator;
A proximal end connected to the housing, and an outer tube having a distal end, the outer tube defining a constant longitudinal axis, and
An actuating element that is reciprocally disposed in the outer tube, the actuating element being operably connected to the actuator; and
An ultrasonic waveguide disposed in the outer tube, the ultrasonic waveguide having an end-effector extending from a distal end portion of the outer tube toward a distal end side; ,
The end-effector has a wide edge portion and a narrow edge portion, the narrow edge portion being defined by a line of intersection of the first surface portion and the second surface portion, wherein the first surface portion is Extending proximally into the end-effector to define a length of the first surface portion; and
A clamp arm pivotally attached to the distal end of the outer tube, the clamp arm being attached to the end-effector for clamping tissue between the clamp arm and the end-effector The swivel movement occurs around a certain horizontal axis, and the arc in the swivel movement of the clamp arm defines a certain vertical plane, the vertical plane being the longitudinal axis and the horizontal Having a constant vertical axis orthogonal to both axes, the clamp arm being operably connected to the actuating element, and reciprocating movement of the actuating element causes the clamp arm to Swivels along a vertical plane,
An ultrasonically clamped coagulator that balances the waveguide such that the constant length of the first surface portion minimizes the deflection of the waveguide in the vertical plane.
(2) The ultrasonic clamp type coagulation apparatus according to the first embodiment, wherein the displacement of the end-effector along the vertical axis is limited to 15% or less.
(3) The ultrasonic clamp type coagulation apparatus according to the first embodiment, wherein the displacement of the end-effector along the vertical axis is limited to 10% or less.
(4) The ultrasonic clamp type coagulation apparatus according to the first embodiment, wherein the displacement of the end-effector along the vertical axis is limited to 5% or less.
(5) In a blade for an ultrasonic surgical instrument,
A proximal end;
The tip,
A wide edge,
A narrow edge portion, the narrow edge portion being defined by a line of intersection of the first surface portion and the second surface portion, wherein the first surface portion is directed from the distal end portion toward the proximal end portion. Extending to the proximal side in the blade and defining a certain length of the first surface portion,
The first surface portion has a length that balances the blade such that the displacement of the secondary end portion of the blade is limited to no more than 15% of the displacement of the primary end portion of the blade. Blade for sonic surgical instruments.
(6) The ultrasonic surgical instrument according to embodiment 5, wherein the displacement of the secondary end portion of the blade is 10% or less of the displacement of the primary end portion of the blade.
(7) The ultrasonic surgical instrument according to embodiment 5, wherein the displacement of the secondary end portion of the blade is 5% or less of the displacement of the primary end portion of the blade.
(8) The ultrasonic surgical instrument according to embodiment 5, wherein the first surface portion is concave.
(9) The ultrasonic surgical instrument according to embodiment 6, wherein the first surface portion is concave.
(10) The ultrasonic surgical instrument according to Embodiment 7, wherein the first surface portion is concave.

(11) The ultrasonic surgical instrument according to embodiment 8, wherein the second surface portion is convex.
(12) The ultrasonic surgical instrument according to embodiment 9, wherein the second surface portion is convex.
(13) The ultrasonic surgical instrument according to embodiment 10, wherein the second surface portion is convex.
(14) In a method of equilibrating an ultrasonic blade,
(A) selecting the maximum allowable amount of undesired blade excursions;
(B) adding a functional asymmetric portion to the blade by removing a quantity of material from a portion of the blade along a length along the blade, the constant asymmetric portion of the functional asymmetric portion being included A method in which the length satisfies an acceptable amount of undesired excursions identified in step (A).
(15) The method of equilibrating an ultrasonic blade according to embodiment 14, wherein the maximum allowable amount of undesired blade deflection in step (A) is a standardized deflection amount of 15%.
16. The method of equilibrating an ultrasonic blade according to embodiment 14, wherein the maximum allowable amount of undesired blade deflection in step (A) is a standardized deflection amount of 10%.
(17) The method of equilibrating an ultrasonic blade according to embodiment 14, wherein the maximum allowable amount of undesired blade deflection in step (A) is a standardized deflection amount of 5%.
(18) In the step (B), the functional asymmetric part is a narrow edge part, and the narrow edge part is defined by a line of intersection between the first surface part and the second surface part, A first surface portion extending proximally into the blade from a tip of the blade toward a proximal end of the blade, defining a fixed length of the functional asymmetric portion; And
The blade is equilibrated so that a constant length of the functional asymmetric portion causes the displacement of the secondary end portion of the blade to be no more than 15% of the displacement of the primary end portion of the blade. Embodiment 15. A method of equilibrating an ultrasonic blade according to embodiment 14.

1 illustrates an ultrasonic surgical system including a side view of an ultrasonic generator, a cross-sectional view of an ultrasonic transducer, and a partial cross-sectional view of a clamped coagulator according to the present invention. It is a disassembled perspective view of a part of the clamp type solidification device by the present invention. It is a disassembled perspective view of a part of the clamp type solidification device by the present invention. 1 is a partial cross-sectional view of a clamp coagulator according to the present invention with a clamp arm assembly shown in an open state. FIG. 1 is a partial cross-sectional view of a clamp coagulator according to the present invention with a clamp arm assembly shown in a closed state; FIG. It is a side view of the color cap in the said clamp type solidification apparatus. It is a front view of the color cap in the said clamp type solidification apparatus. It is a side view of the spring for force restriction in the above-mentioned clamp type solidification device. It is a front view of the spring for force restriction in the above-mentioned clamp type solidification device. It is a side view of the washer in the above-mentioned clamp type solidification device. It is a front view of the washer in the above-mentioned clamp type solidification device. It is a side view of the tubular collar in the above-mentioned clamp type solidification device. It is a rear view of the tubular collar in the above-mentioned clamp type solidification device. It is a front view of the tubular collar in the above-mentioned clamp type solidification device. It is a side view of the inner side knob in the said clamp type solidification apparatus. It is a front view of the inner side knob in the said clamp type solidification apparatus. It is a bottom view of the inner side knob in the said clamp type solidification apparatus. It is a rear view of the outer side knob in the said clamp type solidification apparatus. It is a top view of the outer side knob in the said clamp type solidification apparatus. It is a top view of the yoke in the said clamp type solidification apparatus. It is a side view of the yoke in the said clamp type solidification apparatus. It is a front view of the yoke in the said clamp type solidification apparatus. It is a perspective view of the yoke in the said clamp type solidification apparatus. It is a perspective view of the end-effector in the said clamp type coagulation apparatus. It is a top perspective view of the clamp arm in the above-mentioned clamp type solidification device. It is a top view of the end-effector in the said clamp type coagulation apparatus. It is a side view of the end-effector in the said clamp type solidification apparatus with a clamp arm in an open state. It is a top view of the tissue pad in the said clamp type coagulation apparatus. It is a side view of the tissue pad in the said clamp type coagulation apparatus. It is a front view of the tissue pad in the said clamp type coagulation apparatus. It is a perspective view of the tissue pad in the said clamp type coagulation apparatus. It is a lower perspective view of the clamp arm in the clamp type solidification device. FIG. 32 is a first cross-sectional view of the clamp arm shown in FIG. 31. FIG. 32 is a second cross-sectional view of the clamp arm shown in FIG. 31. It is a bottom view of the braid | blade in the said clamp type solidification apparatus. It is sectional drawing of the braid | blade in the said clamp type solidification apparatus. It is sectional drawing of the braid | blade in another embodiment of the said clamp type solidification apparatus. It is a perspective view of the end-effector in the said clamp type coagulation apparatus.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Ultrasonic system 15 Ultrasonic signal generator 20 Hand piece housing 80 Acoustic assembly 82 Ultrasonic transducer 120 Clamp-type coagulator 130 Instrument housing 150 Elongated member 179 Ultrasonic waveguide 180 End-effector 300 Clamp arm assembly Solid

Claims (10)

In ultrasonic surgical instruments,
An ultrasonic transmission member having a proximal end and a distal end;
An ultrasonically actuated blade attached to the tip of the ultrasonic transmission member,
The blade is
Tip,
A proximal end attached to the ultrasonic transmission member at a nodal point of longitudinal vibration; and
A curved working portion defining an asymmetric plane and having ultrasonically actuated movement in a substantially single plane;
Comprising
A blade,
A clamping member supported adjacent to the blade,
The clamp member has an open position where at least a portion of the clamp member is away from the blade, and a closed position where the clamp member is adjacent to the blade;
The movement from the closed position to the open position occurs in a plane substantially perpendicular to the plane in which the blade moves;
A clamp member;
An ultrasonic surgical instrument comprising: The ultrasonic surgical instrument of claim 1, wherein
An ultrasonic surgical instrument wherein the blade is on a single plane perpendicular to the asymmetric plane. The ultrasonic surgical instrument of claim 1, wherein
The curved working portion further comprises a balancing asymmetric portion;
An ultrasonic surgical instrument wherein the balancing asymmetric portion is positioned to counteract the torque generated at the proximal end of the blade by the functional asymmetric portion. The ultrasonic surgical instrument of claim 3,
The ultrasonic surgical instrument, wherein the balancing asymmetric portion is positioned such that lateral vibration in at least one axis of the tip of the blade is substantially equal to zero. The ultrasonic surgical instrument of claim 3,
An ultrasonic surgical instrument, wherein the balancing asymmetric portion extends from the tip of the blade to a position within the curved working portion. The ultrasonic surgical instrument of claim 3,
An ultrasonic surgical instrument, wherein the balancing asymmetric portion extends from the tip of the blade to a position proximate to the curved working portion. In an ultrasonic surgical instrument comprising an ultrasonic waveguide having a proximal end and a distal end,
The ultrasonic waveguide is
A blade that is balanced and actuated by ultrasound,
The blade is disposed at the tip of the waveguide and has an ultrasonically actuated movement in a substantially single plane;
The blade is
Tip,
The proximal end, and
A curved working portion comprising a balancing portion including at least one balancing asymmetric portion, wherein the balancing asymmetric portion is arranged to counteract the torque produced by the curved working portion. Action part,
Comprising
A blade,
A clamping member supported adjacent to the blade,
The clamp member has an open position where at least a portion of the clamp member is away from the blade, and a closed position where the clamp member is adjacent to the blade;
The movement from the closed position to the open position occurs in a plane substantially perpendicular to the plane in which the blade moves;
A clamp member;
An ultrasonic surgical instrument comprising: In ultrasonic surgical instruments,
A tubular sheath having a diameter, a proximal end, and a distal end;
An ultrasonic transmission member having a proximal end portion and a distal end portion disposed in the tubular sheath;
An ultrasonically actuated blade,
The blade is attached to the distal end portion of the ultrasonic transmission member, and extends to the tip of the distal end portion of the tubular sheath,
The blade is
Tip,
A proximal end attached to the ultrasonic transmission member at a nodal point of longitudinal vibration; and
A curved working part, which defines an asymmetric plane and has an ultrasonically actuated movement in a substantially single plane;
Comprising
A blade,
A clamping member,
The clamp member is configured to draw an arc larger than the diameter of the tubular shaft, and is supported adjacent to the blade;
The clamp member has an open position where at least a portion of the clamp member is away from the blade, and a closed position where the clamp member is adjacent to the blade;
The movement from the closed position to the open position occurs in a plane substantially perpendicular to the plane in which the blade moves;
A clamp member;
An ultrasonic surgical instrument comprising: The ultrasonic surgical instrument of claim 8,
A rotatable member operably linked to the ultrasonic transmission member, the clamp member, and the blade;
Further comprising
The ultrasonic surgical instrument, wherein the rotatable member is rotatable, thereby causing a corresponding rotation of the clamping member and the blade about the longitudinal axis of the instrument. The ultrasonic surgical instrument of claim 8,
A seal member disposed on the ultrasonic transmission member so as to suppress undesired torque caused by the functional asymmetric portion;
An ultrasonic surgical instrument further comprising:

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